BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Xenotron Xenon (Xe 133) Gas Dispenser

    Reg #: 3011353845 · FEI: 1946929 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Curium US LLC
    Registration Number
    3011353845
    FEI Number
    1946929
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2703 Wagner Pl
    City
    Maryland Heights
    State
    MO
    ZIP
    63043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K843640

    Owner / Operator

    Firm Name
    Curium US LLC
    Operator Number
    10051585
    Address
    2703 Wagner Place
    City
    Maryland Heights
    State
    MO
    Postal Code
    63043
    Country
    US
    Correspondent
    Amit Jain

    Products

    Device Name Product Code
    System, Rebreathing, Radionuclide IYT

    Proprietary Names

    Xenotron Xenon (Xe 133) Gas Dispenser

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198